510(k) Report

Devices descending from K210289

2 later devices reach Infant Phototherapy Equipment through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251308SnugLit (TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical Products20260—
+1K243372BiliWrapGerium Medical, Ltd.20250—